BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3942295 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23076
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A RUPTURED RESERVOIR. THE RESERVOIR WAS MICROSCOPICALLY EXAMINED AND MARKINGS WOULD FOUND NEAR THE RUPTURE LINE. THE DEVICE WAS VERIFIED FOR THE REPORTED CONDITION AND FURTHER FUNCTIONAL TESTING WAS NOT REQUIRED. THE CAUSE OF THE NONCONFORMANCE WAS UNKNOWN. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A CAPA WAS OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A HALF DAY INFUSOR RUPTURED. THE DEVICE WAS FILLED WITH 3G OF DEFEROXAMINE AND 40ML OF WATER FOR INJECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418963 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B032

    Patients

    Seq Age Sex Outcome Treatment
    1